U.S. Regulatory Regime of GMO's - Jurisdiction Of The EPA

As I previously wrote in an introductory article, three federal agencies are primarily responsible for the regulation of genetically engineered foods. This article will discuss the types of genetically modified substances that the Environmental Protection Agency (“EPA” or “Agency”) regulates.

EPA’s Jurisdiction

Any substance produced and used in a living plant, whether through conventional breeding or genetic modification is regulated by the EPA if it is intended to control pests.[i] As such, the EPA has a role in regulating the following types of genetically modified organisms:

  1. Plant-Incorporated Protectants (PIPs) – these are plants that produce pesticidal proteins or other chemicals as a result of a transfer of specific genetic material from a bacterium into that plant. Using this biotechnology, for example, scientists have modified corn, cotton, and potatoes to produce a pesticidal protein that is toxic when ingested by specific insect pests. The plant’s modified DNA now expresses pesticidal properties by producing a bacterial protein that is said to protect the plant from specific insects.
  2. Genetically Modified Microbial Pesticides – Genetically modified microbial pesticides are either bacteria, fungi, viruses, protozoa, or algae, whose DNA has been modified to express pesticidal properties. The modified microorganism generally performs as a pesticide’s active ingredient. For example, certain fungi can control the growth of specific types of weeds, while other types of fungi can kill certain insects. Many of the products engineered to contain genetically modified microbial pesticides are typically applied in a spray solution.
  3. Herbicide-Tolerant Crops – Because farmers use broad-spectrum herbicides to control weeds, the herbicides may endanger the crop itself. Herbicide resistant crops, however, have been modified to contain new genes that allow the plant to tolerate these herbicides. The most common herbicide-tolerant crops (cotton, corn, soybeans, and canola) are those that are resistant to glyphosate, an herbicide used on many species of grasses, broadleaf weeds, and sedges. It is worth noting that the EPA does not regulate the crops themselves – that role is performed by the USDA -rather the EPA regulates only the herbicide.[ii]

My next article will evaluate the legal authority pursuant to which the EPA regulates GMOs.


[i] Pew Initiative on Food and Biotechnology, Guide to U.S. Regulation of Genetically Modified Food and Agricultural Biotechnology Products (2001), available at http://www.pewtrusts.org/uploadedFiles/wwwpewtrustsorg/Reports/Food_and_Biotechnology/hhs_biotech_0901.pdf (last visited on August 12, 2009).

[ii] EPA’s Regulation of Biotechnology for Use in Pest Management (June 2003), available at http://www.epa.gov/opp00001/biopesticides/reg_of_biotech/eparegofbiotech.htm (last visited on August 9, 2009).